First-Ever FDA clearance for cement-augmented pedicle screws

First-Ever FDA Clearance for Cement-Augmented Pedicle Screws (ODTMag)
Medtronic plc has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the CD Horizon Fenestrated Screw Set, which can be used for patients diagnosed with advanced stage tumors involving the thoracic and lumbar spine. This marks the first U.S. clearance for cement-augmented pedicle screws. The CD Horizon Fenestrated Screws are used with Medtronic's HV-R Fenestrated Screw Cement, a polymethylmethacrylate (PMMA) cement, and are intended for use at spinal levels where the structural integrity of the spine is no...